Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2025-12-25 @ 11:30 PM
Study NCT ID:
NCT05377593
Status:
COMPLETED
Last Update Posted:
2024-06-04
First Post:
2022-05-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Using Patient Specific Zirconium Dioxide Implant Versus Patient Specific Titanium Implant in Treatment of Chronic Condylar Dislocation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A Randomized Clinical Trial A Trial will be carried out in hospital of Oral and Maxillofacial Surgery department- Faculty of dentistry Cairo University.\n\nEqual Randomization: Participants receiving treatment. Positive Controlled: Both groups receiving treatment. Parallel group study: each group of patients receives single treatment simultaneously.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-02', 'studyFirstSubmitDate': '2022-05-10', 'studyFirstSubmitQcDate': '2022-05-16', 'lastUpdatePostDateStruct': {'date': '2024-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in Maximal inter incisal distance between pre-operative and post-operative (mm)', 'timeFrame': '6 months', 'description': 'using a caliper the difference between preoperative and postoperative Maximal interincisal opening is recorded (mm)'}], 'secondaryOutcomes': [{'measure': "Patient's Pain", 'timeFrame': '6 months', 'description': 'in terms of visual analogue scale (0-10)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Recurrent Dislocation of Temporomandibular Joint (Disorder)']}, 'descriptionModule': {'briefSummary': 'Alternate hypothesis that treatment of Tempromandibular joint dislocation with Zirconium Dioxide eminoplasty will be more efficient than using titanium onlays in terms of decreasing maximum inter incisal distance and providing better soft tissue response and post-operative patient satisfaction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '48 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with recurrent dislocation with maximum inter incisal opening over 55mm\n* Long-standing dislocation of the TMJ involving both fixation for more than 3 weeks and the failure of manual reduction\n* Failure of conservative strategies such as orientation to self-limit jaw movement and the use of a chin-cap or bandage\n* Both sexes\n* Age between 18 and 48 years.\n* Highly motivated patients.\n\nExclusion Criteria:\n\n* Post-menopausal females with osteoporosis\n* Patient with uncontrolled systemic disease\n* pregnancy\n* psychological disorders, drug or alcohol dependency\n* Known allergies or sensitivities to dental materials, including Zirconia, Titanium or general anesthetic agents\n* Inability to return for follow up visits.\n* Refusal of participation from the patient'}, 'identificationModule': {'nctId': 'NCT05377593', 'briefTitle': 'Evaluation of Using Patient Specific Zirconium Dioxide Implant Versus Patient Specific Titanium Implant in Treatment of Chronic Condylar Dislocation', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Evaluation of Using Patient Specific Zirconium Dioxide Implant Versus Patient Specific Titanium Implant in Treatment of Chronic Condylar Dislocation. A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'OMFS 3-3-4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'eminoplasty with patient specific Titanium onlay implant', 'interventionNames': ['Device: eminoplasty with patient specific Zirconium dioxide onlay implant']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'eminoplasty with patient specific zirconium dioxide onlay implant', 'interventionNames': ['Device: eminoplasty with patient specific Zirconium dioxide onlay implant']}], 'interventions': [{'name': 'eminoplasty with patient specific Zirconium dioxide onlay implant', 'type': 'DEVICE', 'description': 'Eminoplasties will be done for patient with chronic condylar dislocation using patient specific zirconium dioxide implants', 'armGroupLabels': ['eminoplasty with patient specific Titanium onlay implant', 'eminoplasty with patient specific zirconium dioxide onlay implant']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Adham Zakaria', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Mohammed Kadry Nasr, Doctorate', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Lecturer at Oral and Maxillofacial Surgery department, Faculty of dentistry, Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Teaching Assistant at Oral and Maxillofacial Sugery department, Faculty of dentistry', 'investigatorFullName': 'Adham Zakaria', 'investigatorAffiliation': 'Cairo University'}}}}